510(k) · Cleared
ClearedPULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.B.M. Sas (Science & Bio Materials) · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 16, 2020 as substantially equivalent to K151004 (Sbm Sciences For Bio Materials, 2015) after a 72-day review. Its family tree reaches back 10 generations to 1990. 1 later device descends from it.
- Decided
- Oct 16, 2020
- Review
- 72 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K904436 (1990). 62 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 6 generations between
- 3 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 2 generations backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- 1 generation backK151004 PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials · 2015
- This deviceK202193 PULLUP BTB Adjustable Fixation System for Ligament Reconstruction…S.B.M. Sas (Science & Bio Materials) · 2020
- Descendant · cites it directly · 0 of its ownK250844 PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T…Science & Bio Materials (S.B.M.) Sas · 2025
Show all 10 generations
- Root · 10 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 9 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 8 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 7 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 6 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 5 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 4 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 3 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 2 generations backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- 1 generation backK151004 PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials · 2015
- This deviceK202193 PULLUP BTB Adjustable Fixation System for Ligament Reconstruction…S.B.M. Sas (Science & Bio Materials) · 2020
Most influential descendants
Showing 1 of 1 · See all- K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −9 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −8 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −7 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −6 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −5 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −4 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −3 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| −2 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| −1 | K151004 | PULLUP® Adjustable Juxtacortical Fixation Device | Sbm Sciences For Bio Materials | 2015 | — |
| 0 (this device) | K202193 | PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP… | S.B.M. Sas (Science & Bio Materials) | 2020 | — |
| +1 | K250844 | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™… | Science & Bio Materials (S.B.M.) Sas | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151004 | PULLUP® Adjustable Juxtacortical Fixation DeviceSummary page 5…Page 1 of 3 K202193 3. PREDICATE DEVICE K151004 - PULLUP® Adjustable Juxtacortical Fixation Device Referenced devices : K092533 - FORCE FIBER® BLUE ULTRA HIGH MOLECULAR WEIGHT… | 2015 |
| † | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures | 2009 |
| † | K930739 | Sutures Polyprop., Polyetheline, Nylon & Silk | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250844 | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 10 of the 62 ancestors have a recall of any class.
- Of its descendants, K250844 (Science & Bio Materials (S.B.M.) Sas, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K151004.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The PULLUP® BTB, BT LOOP®, PULLUP® CLIP & PULLUP® TEX CLIP devices are designed to be used as cortical fixation for ACL reconstruction.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202193: PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202193
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026